Decreasing dose protocol for omalizumab treatment in oral corticosteroid allergic asthma patients

Purpose: To evaluate the viability of a protocol for the progressive decrease of omalizumab dose in allergic GINA step V asthma patients. Methods: To enter the protocol, the patients had to be receiving treatment with omalizumab for a minimum of one year; oral corticosteroid dose had to have reached its lowest level and spirometry had to be ≥ than at entry. Intervention: a) The omalizumab dose was reduced by half; b) If patients were clinically stable after 6 months, the dose was reduced by half again; c) If needed, oral corticosteroid boosters were administered; d) When repeated boosters were needed and/or spirometry worsened, omalizumab dose was increased to the previous figure until the patient stabilized. Results: The protocol started in July 2006 until December 2010. Forty-five adult patients (31 female) were included; three females were lost during follow-up. The omalizumab dose was decreased in 12 patients (26.6%); it was stopped in three and has not been re-introduced after 4, 12 and 21 months. These patients had been treated for 45, 34 and 18 months respectively. Of the nine remaining patients, in six the dose was reduced and did not need to be re-increased; in three the omalizumab dose had to be increased to the initial dose at months 10, 15 and 32. Conclusion: 1) A progressive decrease in the dose of omalizumab was feasible and safe in 26% of the patients. 2) A treatment-free window period is possible, and in one patient lasted up to 21 months.